38486 Federal Register / Vol. 86, No. 137 / Wednesday, July 21, 2021 / Notices 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send your 

comments electronically to http://

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) that are accepting 

comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number:ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at https://www.cms.gov/ 

Regulations-and-Guidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William N. Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–10141 Medicare Prescription 

Drug Benefit Program 

CMS–R–43 Conditions of Coverage for 

Portable X-ray Suppliers and 

Supporting Regulations 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Medicare 

Prescription Drug Benefit Program; Use: 

Plan sponsor and State information is 

used by CMS to approve contract 

applications, monitor compliance with 

contract requirements, make proper 

payment to plans, and ensure that 

correct information is disclosed to 

potential and current enrollees. Form 

Number: CMS–10141 (OMB control 

number: 0938–0964); Frequency: Once; 

Affected Public: Private sector (Business 

or other for-profit and Not-for-profit 

institutions); Number of Respondents: 

11,771,497; Total Annual Responses: 

675,231,213; Total Annual Hours: 

9,312,314. (For policy questions 

regarding this collection contact 

Maureen Connors at 410–786–4132.) 

2. Type of Information Collection 

Request: Revision of a previously 

approved collection; Title of 

Information Collection: Conditions of 

Coverage for Portable X-ray Suppliers 

and Supporting Regulations; Use: The 

requirements contained in this 

information collection request are 

classified as conditions of participation 

or conditions for coverage. Portable Xrays are basic radiology studies 

(predominately chest and extremity Xrays) performed on patients in skilled 

nursing facilities, residents of long-term 

care facilities and homebound patients. 

The CoPs are based on criteria described 

in the law, and are designed to ensure 

that each portable X-ray supplier has 

properly trained staff and provides the 

appropriate type and level of care for 

patients. The information collection 

requirements described below are 

necessary to certify portable X-ray 

suppliers wishing to participate in the 

Medicare program. There are currently 

506 portable X-ray suppliers 

participating in the Medicare program. 

On September 30, 2019 (84 FR 51732), 

CMS updated the personnel 

requirements for portable X-ray 

technicians at 42 CFR 486.104(a), to 

focus on the qualifications of the 

individual performing services 

removing school accreditation 

requirements and simplifying the 

structure of the requirements. 

Additionally, CMS also revised the 

requirements for referral of service at 42 

CFR 486.106(a) for portable X-ray 

requirements for orders. This change 

removed the requirement that physician 

or non-physician practitioner’s orders 

for portable X-ray services must be 

written and signed and replacing the 

specific requirements related to the 

content of each portable X-ray order 

with a cross-reference to the 

requirements at 42 CFR 410.32, which 

also apply to portable X-ray services. 

Form Number: CMS–R–43 (OMB 

Control number: 0938–0338); 

Frequency: Yearly; Affected Public: 

Business or other for-profit and Not-forprofit institutions; Number of 

Respondents: 506; Total Annual 

Responses: 1,012; Total Annual Hours: 

324. (For policy questions regarding this 

collection contact James Cowher at 410– 

786–1948.) 

Dated: July 16, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–15532 Filed 7–20–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10774, CMS– 

10008 and CMS–10450] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected, and the use 

of automated collection techniques or 


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Federal Register / Vol. 86, No. 137 / Wednesday, July 21, 2021 / Notices 38487 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by August 20, 2021. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/ 

PaperworkReductionActof1995/PRAListing.html. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (PRA) 

(44 U.S.C. 3501–3520), federal agencies 

must obtain approval from the Office of 

Management and Budget (OMB) for each 

collection of information they conduct 

or sponsor. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: New collection (Request for a 

new OMB control number); Title of 

Information Collection: The 

International Classification of Diseases, 

10th Revision, Procedure Coding 

System (ICD–10–PCS); Use: The HIPAA 

Act of 1996 required CMS to adopt 

standards for coding systems that are 

used for reporting health care 

transactions. The Transactions and Code 

Sets final rule (65 FR 50312) published 

in the Federal Register on August 17, 

2000 adopted the International 

Classification of Diseases, 9th Revision, 

Clinical Modification (ICD–9–CM) 

Volumes 1 and 2 for diagnosis codes 

and ICD–9–CM Volume 3 for inpatient 

hospital services procedures as standard 

code sets for use by covered entities 

(health plans, health care 

clearinghouses, and those health care 

providers who transmit any health 

information in electronic form in 

connection with a transaction for which 

the Secretary has adopted a standard). 

The ICD–10–PCS code set has been 

maintained, enhanced and expanded as 

a direct result of recommendations for 

updates (e.g., adding new codes, 

deleting codes, and editing descriptive 

material related to existing codes) 

received from interested stakeholders 

from both the public and private sectors. 

Thus, information collected in the 

application is significant to code set 

maintenance. The ICD–10–PCS code set 

maintenance is an ongoing process, as 

changes are implemented and updated; 

therefore, the process requires continual 

collection of information from 

applicants on a bi-annual basis. As new 

technology evolves and new complex 

medical procedures are developed, 

requests are submitted to CMS 

requesting modifications to the ICD–10– 

PCS code set. Requests have been 

received prior to HIPAA 

implementation and must continue to 

be collected to facilitate quality 

decision-making. 

The Committee provides two 

meetings each year as a public forum to 

discuss proposed changes to ICD–10. 

Suggestions to CMS for ICD–10–PCS 

procedure code modifications come 

from both the public and private sectors. 

ICD–10–PCS modification requests can 

be proposals for new or revised 

procedure codes or requests for 

technical coding updates including but 

not limited to, enhancements to existing 

procedure code concepts, such as 

adding a new body part value or a new 

approach value. Requestors are asked to 

include a description of the procedure 

code or change being requested, and 

rationale for why the procedure code or 

change is needed. Supporting references 

and literature may also be submitted. 

Interested parties submit these ICD–10– 

PCS modification requests three months 

prior to a scheduled Spring or Fall C&M 

meeting via email to the following email 

address: ICDProcedureCodeRequest@

cms.hhs.gov. Form Number: CMS– 

10744 (OMB control number: 0938– 

New); Frequency: Yearly; Affected 

Public: Business or other for-profits and 

Not-for-profit institutions and Private 

Sector; Number of Respondents: 80; 

Total Annual Responses: 80; Total 

Annual Hours: 800 (For policy 

questions regarding this collection 

contact Marilu Hue at 410–786–4510.) 

2. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Transitional 

Pass through payments related to Drugs, 

Biologicals, and Radiopharmaceuticals 

to determine eligibility under the 

Outpatient Prospective Payment 

System; Use: Section 201(b) of the 

BBRA 1999 amended section 1833(t) of 

the Act by adding new section 

1833(t)(6). This provision requires the 

Secretary to make additional payments 

to hospitals for a period of 2 to 3 years 

for certain drugs, radiopharmaceuticals, 

biological agents, medical devices and 

brachytherapy devices. Section 

1833(t)(6)(A)(iv) establishes the criteria 

for determining the application of this 

provision to new items. Section 

1833(t)(6)(C)(i) provides that the 

additional payment for drugs and 

biologicals be the amount by which the 

amount determined under section 

1842(o) of the Act exceeds the portion 

of the otherwise applicable hospital 

outpatient department fee schedule 

amount that the Secretary determines to 

be associated with the drug or 

biological. 

Interested parties such as hospitals, 

pharmaceutical companies, and 

physicians will apply for transitional 

pass-through payment for drugs, 

biologicals, and radiopharmaceuticals 

used with services covered under the 

hospital OPPS. After we receive all 

requested information, we will evaluate 

the information to determine if the 

criteria for making a transitional passthrough payment are met and if an 

interim healthcare common procedure 

coding system (HCPCS) code for a new 

drug, biological, or radiopharmaceutical 

is necessary. We will advise the 

applicant of our decision, and update 

the hospital OPPS during its next 

scheduled quarterly update to reflect 

any newly approved drug, biological, or 

radiopharmaceutical. We list below the 

information that we will require from all 

applicants. Form Number: CMS–10008 

(OMB control number: 0938–0802); 

Frequency: Yearly; Affected Public: 

Private Sector; Number of Respondents: 

30; Total Annual Responses: 30; Total 

Annual Hours: 480 (For policy 

questions regarding this collection 

contact Raymond A. Bulls at 410–786– 

7267.) 

3. Type of Information Collection 

Request: Extension of a currently 

approved Information Collection; Title 

of Information Collection: Consumer 

Assessment of Healthcare Providers and 


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38488 Federal Register / Vol. 86, No. 137 / Wednesday, July 21, 2021 / Notices 

Systems (CAHPS) Survey for Meritbased Incentive Payment Systems 

(MIPS); Use: CMS is submitting updates 

to one information collection request 

associated with the CAHPS for MIPS 

survey. The CAHPS for MIPS survey is 

used in the Quality Payment Program 

(QPP) to collect data on fee-for-service 

Medicare beneficiaries’ experiences of 

care with eligible clinicians 

participating in MIPS and is designed to 

gather only the necessary data that CMS 

needs for assessing physician quality 

performance, and related public 

reporting on physician performance, 

and should complement other data 

collection efforts. The survey consists of 

the core Agency for Healthcare Research 

and Quality (AHRQ) CAHPS Clinician & 

Group Survey, version 3.0, plus 

additional survey questions to meet 

CMS’s information and program needs. 

The survey information is used for 

quality reporting, the Care Compare 

website, and annual statistical 

experience reports describing MIPS data 

for all MIPS eligible clinicians. 

This 2021 information collection 

request addresses changes to the CAHPS 

for MIPS Survey associated with the CY 

2021 Physician Fee Schedule (PFS) final 

rule. In order to address the increased 

use of telehealth care due to the Public 

Health Emergency (PHE) for COVID–19, 

an additional question is added to the 

CAHPS for MIPS survey to integrate one 

telehealth item to assess the patientreported usage of telehealth services. In 

addition, the cover page of the CAHPS 

for MIPS Survey is revised to include a 

reference to care in telehealth settings. 

The CAHPS for MIPS survey results in 

burden to three different types of 

entities: Groups and virtual groups, 

vendors, and beneficiaries associated 

with administering the survey. Virtual 

groups are subject to the same 

requirements as groups; therefore, we 

will refer only to groups as an inclusive 

term for both unless otherwise noted. 

The estimated time to administer the 

2021 CAHPS for MIPS survey has 

increased from 12.9 minutes to 13.1 

minutes; however, there was an overall 

decrease in burden as the number of 

respondents decreased. Form Number: 

CMS–10450 (OMB control number: 

0938–1222); Frequency: Yearly; 

Affected Public: Business or other forprofits and Not-for-profit institutions 

and Individuals and Households; 

Number of Respondents: 30,249; Total 

Annual Responses: 30,249; Total 

Annual Hours: 6,902 (For policy 

questions regarding this collection 

contact Alesia Hovatter at 410–786– 

6861.) 

Dated: July 16, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–15531 Filed 7–20–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; National Survey of Early Care 

and Education COVID–19 Follow-Up 

(OMB #0970–0391) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, HHS. 

ACTION: Request for public comment. 

SUMMARY: The Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), plans to request from 

the Office of Management and Budget 

(OMB) an extension to complete data 

collection for a two-wave COVID–19 

Follow-up data collection currently 

underway as part of the National Survey 

of Early Care and Education (NSECE). 

The objective of the NSECE COVID–19 

Follow-up is to document the nation’s 

current supply of early care and 

education services (that is, home-based 

providers, center-based providers, and 

the center-based provider workforce). 

There are no changes proposed. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

forwarded by emailing 

OPREinfocollection@acf.hhs.gov. 

Alternatively, copies can also be 

obtained by writing to the 

Administration for Children and 

Families, Office of Planning, Research, 

and Evaluation, 330 C Street SW, 

Washington, DC 20201, Attn: OPRE 

Reports Clearance Officer. All requests, 

emailed or written, should be identified 

by the title of the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: In the context of the 

COVID–19 pandemic, the NSECE 

COVID–19 Follow-up will deepen our 

understanding of the state of ECE 

supply and the ECE workforce following 

the initial period of crisis, including 

changes in supply or departures from 

and re-entries to the workforce. The 

NSECE COVID–19 Follow-up will 

collect information from center-based 

ECE providers to children birth through 

age 5 years, not yet in kindergarten, 

home-based ECE providers that serve 

children under age 13, as well as the 

ECE workforce providing these services. 

The collection consists of three 

coordinated nationally representative 

surveys: 

1. A two-wave survey of individuals 

who provided paid care for children 

under the age of 13 in a residential 

setting as of 2019 and participated in 

the 2019 NSECE (Home-based Provider 

Interview), 

2. a two-wave survey of providers of 

care to children ages 0 through 5 years 

of age (not yet in kindergarten) in a nonresidential setting (Center-based 

Provider Interview) as of 2019 and that 

participated in the 2019 NSECE, and 

3. a two-wave survey conducted with 

individuals employed in center-based 

child care programs working directly 

with children in classrooms (Centerbased Classroom Staff [Workforce] 

Interview) as of 2019 and who 

participated in the 2019 NSECE. 

Respondents: Home-based providers 

as of 2019 serving children under 13 

years (listed and unlisted paid)— 

regardless of their status serving 

children in 2020–2022, center-based 

child care providers as of 2019 serving 

children ages 0 through 5 years of age 

(not yet in kindergarten)—regardless of 

their status serving children in 2020– 

2022, and classroom-assigned 

instructional staff members working 

with children ages 0 through 5 years of 

age (not yet in kindergarten) in centerbased child care providers as of 2019, 

regardless of their employment status in 

2020–2022. 

Annual Burden Estimates: This 

request is for an extension through 

spring 2022. 


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